UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021987 |
|---|---|
| Receipt number | R000025343 |
| Scientific Title | Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo) |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2019/04/09 11:04:13 |
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Basic information
Public title
Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Acronym
Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Scientific Title
Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Scientific Title:Acronym
Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Region
| Japan |
Condition
Condition
Glucocorticoid-Induced Osteoporosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Pneumology |
| Nephrology | Neurology | Clinical immunology |
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of switching to weekly teriparatide with the continuation of bisphosphonate in patients with glucocorticoid-induced osteoporosis who is taking bisphosphonate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the change of bone mineral density in hip and lumbar spine (L1-4).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Teriparatide arm: Patients receive weekly teriparatide with a discontinuation of bisphosphonate. At week 72, patients stop receiving teriparatide and are switched back to bisphosphonate. At week 144, final observation is performed.
Interventions/Control_2
Bisphosphonate arm: Patients continue to receive residual bisphosphonate until week 144.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age at 20 yaers old or more.
2) Paitnets who recieve glucocorticoid (PSL 5mg or more) and bisphosphonate more than 6 months.
3) BMD of lumber spine (L1-4) or hip (neck or total) by DEXA is T-score of -2.0 or less, or T-score of -1.0 or less who have a history of fragility fracture.
4) Written informed consent required.
Key exclusion criteria
1) Patients whose BMD of 3 or more of lumbar spines cannot be analysed because of fracture or artificial materials.
2) Contraindication for bisphosphonate or teriparatide.
3) Patients who have received teriparatide or denosumab.
4) Patients with active infection or malignancy.
5) Age less than 20 years old.
6) Patients who is currently pregnant, breastfeeding or willing to get pregnant.
7) Patients who do not give consent to the study.
8) Patients who are judged to be inappropriate by the physician.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Kono / Toshihiro Nanki |
Organization
Teikyo University School of Medicine (Hajime Kono)
Toho University School of Medicine (Toshihiro Nanki)
Division name
Department of Internal Medicine (Hajime Kono) Division of Rheumatology, Department of Internal Medicine (Toshihiro Nanki)
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan (Hajime Kono)/6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan (Toshihiro Nanki)
TEL
03-3762-4151(6851)
toshihiro.nanki@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Kono / Toshihiro Nanki |
Organization
Teikyo University School of Medicine (Hajime Kono) Toho University School of Medicine (Toshihiro Nan
Division name
Department of Internal Medicine (Hajime Kono) Division of Rheumatology, Department of Internal Medic
Zip code
Address
2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan (Hajime Kono)/6-11-1 Omori-nishi, Ota-ku, Tokyo 143-
TEL
03-3762-4151(6851)
Homepage URL
toshihiro.nanki@med.toho-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine (Hajime Kono)
Toho University School of Medicine (Toshihiro Nanki)
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Pharma Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝京大学医学部附属病院（東京都）、熊本大学医学部附属病院（熊本県）、香川大学医学部附属病院（香川県）、 国家公務員共済組合連合会横浜南共済病院（神奈川県）、東京都健康長寿医療センター（東京都）、横浜市立大学病院（神奈川県）、宇多津病院（香川県）、善仁会市民の森病院（宮崎県）、兵庫医科大学病院（兵庫県）、さぬき市民病院（香川県）、ひろせクリニック（埼玉県）、医療法人財団医道会十条武田リハビリテーション病院（京都府）、徳島大学病院（徳島県）、下北沢病院（東京都）、そしがや大蔵クリニック（東京都）、ひらまつ内科（東京都）、川崎市立川崎病院（神奈川県）、東京都立墨東病院（東京都）、多摩総合医療センター（東京都）、埼玉医科大学病院（埼玉県）、東京女子医科大学附属膠原病リウマチ痛風センター（東京都）、香音クリニック（山形県）、市立札幌病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025343
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